BladderScan BVI 9600 with AortaScan mode portable ultrasound instrument 의 리콜

Recall

RC-2015-RN-01212-1

Class I

2015-12-11

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01212-1

The device is currently indicated for obtaining an image of the abdominal aorta for aortic diameter measurement. due to the design characteristics, the abdominal aortic measurement (aaa) reported by the device may be significantly smaller (or larger) than the actual diameter of the abdominal aorta. the devices can measure abdominal aortic diameters ranging from 3 to 12.4 cm with a diameter accuracy of ± 15% ± 0.5 cm. for example, a true abdominal aortic diameter of 5.3 cm may be reported to be as low as 4.01 cm or as large as 6.60 cm. in another example, a true abdominal aortic diameter of 3.5 cm may be reported to be as low as 2.48 cm or as large as 4.53 cm.Serious injuries and/or deaths could occur due to the failure mode associated with the issue. verathon have received a report of one (1) serious injury due to this issue.

The updated Operations and Maintenance Manuals clarify that these devices should not be used for the screening, detection, or diagnosis of AAAs. Because of the potential variation in measurement and the serious health risks associated with undetected AAAs, Verathon is reminding users that, if clinically indicated, appropriate patients should be referred for a diagnostic standard test for either screening for or diagnosis of an AAA regardless of test results obtained with BladderScan BVI 9600 device. This action has been closed-out on 24/08/2016.